Application 088539

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCORTISONE	HYDROCORTISONE	TABLET;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088539-001	HYDROCORTISONE	HYDROCORTISONE	10MG	TABLET / ORAL			1984-03-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088539-001	HYDROCORTISONE	10MG	TABLET / ORAL	1984-03-21	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 20 · 400 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone 1% Anti-Itch Cream	HYDROCORTISONE	DLC Laboratories, Inc.	16eeec2c-065d-4da0-e063-6294a90a3873	2026-01-07	Warnings	Name fallback generic name: HYDROCORTISONE
Maximum Strength Hydrocortisone	HYDROCORTISONE	DLC Laboratories, Inc	caf50f12-f35c-4e9e-8ef7-3b0c84e225ee	2026-01-07	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Padagis Israel Pharmaceuticals Ltd	7ba59aa6-b828-4048-bf86-90c90d9894a0	2026-01-06	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Procto-Med HC	HYDROCORTISONE	Leading Pharma, LLC	0682580e-aff8-4b67-99ba-a29ab7b433db	2026-01-06	Adverse reactions	Name fallback generic name: HYDROCORTISONE
HYDROCORTISONE	ANTI-ITCH CREAM	Water-Jel Technologies	3d34ae31-265a-46bc-a52d-546ea5bb24b6	2025-12-31	Warnings	Name fallback brand name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	AKRON PHARMA INC	fa956b6a-1712-4f7a-9490-11866dcd17c8	2025-12-29	Warnings	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Nizoral Scalp Itch Relief	HYDROCORTISONE	Kramer Laboratories	dba59238-6beb-447e-8c4c-e4bc00fd2c20	2025-12-23	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	ANI Pharmaceuticals, Inc.	b2918ac7-14b5-4372-9055-8caf6f4bcf37	2025-12-22	Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Caring Mills Hydrocortisone	HYDROCORTISONE	Veridian Healthcare	b0b1889b-3099-4943-a4cb-d9a898a06860	2025-12-22	Warnings	Name fallback generic name: HYDROCORTISONE
Kroger Anti Itch	HYDROCORTISONE	The Kroger Co	46547277-f11a-b9e7-e063-6294a90a2ccd	2025-12-19	Warnings	Name fallback generic name: HYDROCORTISONE
Aquaphor Itch Relief	HYDROCORTISONE	Beiersdorf Inc	b1d0333f-ba60-35d8-e053-2995a90af932	2025-12-16	Warnings	Name fallback generic name: HYDROCORTISONE
equate hydrocortisone	HYDROCORTISONE	Wal-Mart Stores Inc	70f4636d-4137-498b-ab81-0330de883e53	2025-12-15	Warnings	Name fallback generic name: HYDROCORTISONE
TrueLipids 1% Hydrocortisone Barrier Cream	HYDROCORTISONE	Claridei Laboratories	037395dc-5b96-052e-e063-6394a90a26e4	2025-12-15	Warnings	Name fallback generic name: HYDROCORTISONE
Hydrocortisone Rectal Suspension (Retention)	HYDROCORTISONE	Chartwell RX LLC	3fb69485-bfa5-4751-b0ca-a0a0efb6b2b8	2025-12-10	Warnings, Adverse reactions	Name fallback generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Chartwell RX, LLC.	4b6edbc4-7afb-4fb5-a16e-66ce70916f09	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Hydrocortisone	HYDROCORTISONE	Chartwell RX, LLC	5b707a9f-32b6-42f3-beb6-111df98dfde5	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Hydrocortisone generic name: HYDROCORTISONE
Thompson Hydrocortisone 1%	HYDROCORTISONE	Thompson	f8740314-7e1f-815e-e053-6294a90a6eae	2025-12-05	Warnings	Name fallback generic name: HYDROCORTISONE
ElixirCortiRelief	HYDROCORTISONE	ELIXIR HEALTHCARE USA, LLC.	a6ca66f3-9759-4c98-a758-45700bc08352	2025-12-02	Warnings	Name fallback generic name: HYDROCORTISONE
PEDIADERMICS ECZEMA 2	HYDROCORTISONE	RENU LABORATORIES, LLC	da840bf6-ed65-bafc-e053-2a95a90a92d5	2025-12-02	Warnings	Name fallback generic name: HYDROCORTISONE
Thera Plus Maximum Strength Hydrocortisone	HYDROCORTISONE	Fourstar Group USA, Inc	7d4e21d1-2914-4690-9084-a52abeab0958	2025-12-02	Warnings	Name fallback generic name: HYDROCORTISONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.